310. Assessing for Eligibility

Updated July 1, 2021

Researchers sometimes need to obtain information about or from prospective participants to assess eligibility for research participation.

• Under some conditions, these assessments are considered "activities preparatory to research" and do not require prior IRB approval.
• Under other conditions, such assessment activities constitute human research and require exempt or IRB approval; and may require informed consent, and Health Insurance Portability and Accountability Act (HIPAA) and Family Educational Rights and Privacy Act (FERPA) authorizations.

When IRB Approval Is NOT Required to Assess Eligibility

• Information about the number of eligible prospective participants is necessary to justify the research or to demonstrate the Principal Investigator (PI) could meet enrollment requirements for the study.
• The PI needs the information to prepare a research application.
• The researchers (or others) are authorized to view the records because of their professional responsibilities (e.g., physician reviewing patient records; owner or employee of database).
• The data are recorded by or provided to researchers in aggregate or are collected without Protected Personally Identifiable Information (PPII) and Protected Health Information (PHI) (as defined in IRB Policy Manual Definitions).
• Codes are not used to link PPII or PHI to individual records or data.
• The records remain at the institution or agency that "owns" the data.
• As the phrase implies, activities preparatory to research end when the protocol is submitted to the IRB.
• The PI must obtain any required permissions from the institutional authority responsible for protecting the privacy and confidentiality of the records (NOT IRB approval).

If all of the conditions noted above are met, activities preparatory to research do not require a waiver of consent, HIPAA authorization, or FERPA.

NOTE: Activities preparatory to research can include reviewing database output (computer file or printout) containing PPII or PHI generated by the database owner, if the investigator:

• reviews the information at the institution/agency, and
• returns the database output to the database owner when finished aggregating the information.

When IRB Approval Is Required to Assess Eligibility

Prior IRB approval must be obtained before researchers may assess eligibility for non-exempt* research when screening activities:

• involve "interaction" with prospective participants; or
• include collection and retention of PPII or PHI for research purposes (including when used to contact or recruit prospective participants, or to evaluate recruitment processes or screen failures).

Screening activities include pilot or feasibility studies that involve the collection of PPII or PHI, or interaction with prospective participants.

Informed Consent Requirements to Assess Eligibility

When a researcher will obtain information or biospecimens for the purposes of screening, recruiting, or determining the eligibility of prospective participants in a research project, the researcher may do so without obtaining informed consent if either of the following conditions are met:

• The information is obtained through oral or written communication with the prospective participant.
• The information is obtained by accessing records or biospecimens.

HIPAA Authorization Requirements to Assess Eligibility

Requirements for documentation of HIPAA authorization apply when PHI (i.e., the 18 HIPAA identifiers) will be obtained and retained for research purposes. IRB approval for a waiver of HIPAA authorization may be requested.

PIs must describe the collection of PHI and submit the form that will be used to obtain HIPAA authorization from participants or request IRB approval for a waiver of HIPAA Authorization. HIPAA waivers of authorization are considered effective until the individual participant signs the HIPAA Authorization Form and approved consent form, or up to the date specified in the screening call.

FERPA Authorization Requirements to Assess Eligibility

Requirements for written FERPA authorization apply when PPII will be obtained from education records and retained for research activities although FERPA exceptions exist.

FERPA may not apply to the collection and use of PPII from student education records when:

• only directory information will be collected and the requisite institutional or departmental approval is obtained; or
• the education records are disclosed to organizations conducting studies for or on behalf of educational agencies or institutions.

(For more information, see IRB policy for FERPA exceptions.)

Research Activities for Assessing Eligibility

• Telephone screening
• In-take sessions
• Pre-enrollment assessment or screening activities, including assessment of cognitive function
• Screening questionnaires
• Feasibility studies

Investigators may wish to retain screening information with PPII to recruit individuals for future studies or to keep a record of ineligible participants. Both of these activities require IRB approval and participant consent, and may invoke HIPAA and FERPA requirements. The establishment of a database to obtain and store screening information for future research may require a separate IRB application.